- Device
- NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P820021
- Supplement
- S025
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 1995-12-13
- Decision code
- APPR
- Date received
- 1995-01-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE LENS BLANKS FOR NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES MANUFACTURED AT CIBA VISION CORORATION, 2910 AMWILER COURT, ATLANTA, BA TO BE FINAL CURED, WET PROCESSED, TINTED, PACKGED, AND STERILIZAED AT THE ALTERNATE MANUFACTURING SITE, CIBA VISION BATAM, BATAM INDUSTRIAL PARK, LOT #204, MUKA KUNING 29433, BATAM ISLAND, INDONESIA